Simulations Plus, Inc. (NASDAQ: SLP), a leading provider of simulation and modeling software for pharmaceutical discovery and development, announced that it has released a major upgrade to its gold standard GastroPlus™ software for simulation of absorption, pharmacokinetics, and pharmacodynamics of drugs dosed in oral and intravenous dosage forms.
Dr. Viera Lukacova, team leader for Simulation Technologies for Simulations Plus, said: “In this major update, we’ve incorporated a series of major improvements that we’ve been working on for many months. One of the important uses of GastroPlus is to establish what are called invitro – in vivo (IVIV) correlations. This refers to finding the relationship between how a dosage form dissolves in the lab (in vitro) with how it dissolves in human or animals (in vivo). The understanding of these differences helps scientists in several ways: (1) designing the ideal formulation faster and with fewer experiments, (2) designing an in vitro experiment that is a better representation of in vivo release, and (3) getting better estimates of blood concentration-time profiles for similar new formulations prior to full-blown clinical trials. Traditional methods for doing this were developed years ago when computer power was quite limited by today’s standards, and they were necessarily limited by many simplifying assumptions. The new IVIVCPlus™ Module provides a very fast and convenient way for formulation scientists to perform IVIV correlations, both using traditional methods and with a new method we have developed which has no such limitations, providing more accurate and useful correlations to assist formulation scientists in their work.”
Dr. Lukacova continued: “Another optional module is called PKPlus™. In the past, this module was used to fit pharmacokinetic parameters (mathematical models) to data from a single intravenous dose. This is an important step in understanding how a drug behaves once it enters the body. Now, in response to numerous customer requests, PKPlus can fit multiple data sets at the same time, including a mix of both intravenous and oral doses. This is the fastest and easiest method we know for doing this type of analysis, which is one of the most common activities in analyzing the results of animal and human studies.”
Dr. Michael Bolger, chief scientist for Simulations Plus, said: “Yet another new function in this release of GastroPlus is the ability to predict and track the metabolites that are formed when a drug is converted into a different molecule by enzymes in the body. Knowing how fast metabolites are formed and how they distribute into different tissues and are finally cleared out of the body is important. Some metabolites are therapeutic, while others can cause adverse effects. Understanding how much and how fast both types of metabolites are formed and cleared can assist scientists in determining whether different dose levels are likely to provide good therapeutic response without unacceptable adverse effects. This new capability adds further value to GastroPlus simulations in pharmaceutical research.”
“We also developed a new kidney model that provides more accurate prediction of how drugs are cleared in the urine,” added Dr. Bolger. “This is an important extension of the clearance models in GastroPlus for drugs and metabolites that are cleared by filtration in the kidney. There are many other improvements in this release too numerous to mention. We have designated this version as 6.0 rather than 5.5 because of the magnitude of the changes involved.”
Walt Woltosz, chairman and chief executive officer for Simulations Plus, added: “Dr. Lukacova and her team have done a remarkable job with this major new release. As additional-cost optional modules, the improvements to both IVIVCPlus and PKPlus should enhance GastroPlus’ sales and revenue potential. GastroPlus is already the gold standard in the industry for programs of its type, and these new capabilities push our lead position a bit further ahead. I was in